83 FR 13722 - BASF Plant Science, LP; Availability of Petition for Determination of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile and Resistance to an Imidazolinone Herbicide

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 83, Issue 62 (March 30, 2018)

Page Range		13722-13723
FR Document		2018-06399

We are advising the public that the Animal and Plant Health Inspection Service has received a petition from BASF Plant Science, LP, seeking a determination of nonregulated status of canola designated as event LBFLFK, which has been genetically engineered (GE) to allow for the synthesis of long chain omega-3 polyunsaturated fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), from oleic acid in canola seed. The GE canola has also been genetically engineered for resistance to an imidazolinone herbicide. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms. We are making the BASF Plant Science, LP petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that the Animal and Plant Health Inspection Service may determine should be considered in our evaluation of the petition.

Federal Register, Volume 83 Issue 62 (Friday, March 30, 2018)

[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Notices]
[Pages 13722-13723]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-06399]

[[Page 13722]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2018-0014]

BASF Plant Science, LP; Availability of Petition for
Determination of Nonregulated Status of Canola Genetically Engineered
for Altered Oil Profile and Resistance to an Imidazolinone Herbicide

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from BASF Plant Science, LP,
seeking a determination of nonregulated status of canola designated as
event LBFLFK, which has been genetically engineered (GE) to allow for
the synthesis of long chain omega-3 polyunsaturated fatty acids,
including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA),
from oleic acid in canola seed. The GE canola has also been genetically
engineered for resistance to an imidazolinone herbicide. The petition
has been submitted in accordance with our regulations concerning the
introduction of certain genetically engineered organisms. We are making
the BASF Plant Science, LP petition available for review and comment to
help us identify potential environmental and interrelated economic
issues and impacts that the Animal and Plant Health Inspection Service
may determine should be considered in our evaluation of the petition.

DATES: We will consider all comments that we receive on or before May
29, 2018.

ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0014.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2018-0014, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2018-
0014 or in our reading room, which is located in Room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW, Washington, DC.
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 799-7039 before coming.
The petition is also available on the APHIS website at: http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under
APHIS petition 17-321-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director,
Environmental Risk Analysis Programs, Biotechnology Regulatory
Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236;
(301) 851-3954, email: john.t.turner@aphis.usda.gov. To obtain copies
of the petition, contact Ms. Cindy Eck at (301) 851-3892, email:
cynthia.a.eck@aphis.usda.gov.

SUPPLEMENTARY INFORMATION: Under the authority of the plant pest
provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), the
regulations in 7 CFR part 340, ``Introduction of Organisms and Products
Altered or Produced Through Genetic Engineering Which Are Plant Pests
or Which There Is Reason to Believe Are Plant Pests,'' the Animal and
Plant Health Inspection Service (APHIS) regulates, among other things,
the introduction (importation, interstate movement, or release into the
environment) of organisms altered or produced through genetic
engineering that are plant pests or that there is reason to believe are
plant pests. Such genetically engineered (GE) organisms are considered
``regulated articles.''
The regulations in Sec. 340.6(a) provide that any person may
submit a petition to the Animal and Plant Health Inspection Service
(APHIS) seeking a determination that an article should not be regulated
under 7 CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe
the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.
APHIS has received a petition (APHIS Petition Number 17-321-01p)
from BASF Plant Science, LP, of Florham Park, NJ (BASF), seeking a
determination of nonregulated status of canola (Brassica napus L.)
designated as event LBFLFK, which has been genetically engineered to
allow for the synthesis of long chain omega-3 polyunsaturated fatty
acids (LC-PUFAs), including eicosapentaenoic acid (EPA) and
docosahexaenoic acid (DHA), from oleic acid in canola seed. The GE
canola has also been genetically engineered for resistance to an
imidazolinone herbicide. The BASF petition states that information
collected during field trials and laboratory analyses indicates that
LBFLFK canola is not likely to be a plant pest and therefore should not
be a regulated article under APHIS' regulations in 7 CFR part 340.
As described in the petition, LBFLFK canola was developed through
Agrobacterium rhizogenes-mediated transformation of canola variety
Kumily using a single transformation vector to introduce fatty acid
synthesis genes (desaturases and elongases) and an herbicide resistance
gene. Characterization of the LBFLFK canola event demonstrated that
there are no safety concerns according to the applicant. LBFLFK canola
is currently regulated under 7 CFR part 340. Interstate movements and
field tests of LBFLFK canola have been conducted under APHIS
authorizations.
Field tests conducted under APHIS oversight allowed for evaluation
in a natural agricultural setting while imposing measures to minimize
the risk of dissemination and persistence in the environment after
completion of the tests. Data were gathered on multiple parameters and
used by the applicant to evaluate agronomic characteristics and product
performance. These and other data will be used by APHIS to determine if
the new variety poses a plant pest risk.
Paragraph (d) of Sec. 340.6 provides that APHIS will publish a
notice in the Federal Register providing 60 days for public comment for
petitions for a determination of nonregulated status. On March 6, 2012,
we published in the Federal Register (77 FR 13258-13260, Docket No.
APHIS-2011-0129) a notice \1\ describing our process for soliciting
public comment when considering petitions for determinations of
nonregulated status for GE organisms. In that notice we indicated that
APHIS would accept written comments regarding a petition once APHIS
deemed it complete.
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\1\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
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In accordance with Sec. 340.6(d) of the regulations and our
process for soliciting public input when considering petitions for
determinations of nonregulated status for GE organisms, we are
publishing this notice to inform the public that APHIS will accept
written comments regarding the petition for a determination of
nonregulated status from interested or affected persons for a period of
60 days from the date of this notice. The petition is available for
public review and comment, and copies are available as indicated under
ADDRESSES and FOR

[[Page 13723]]

FURTHER INFORMATION CONTACT above. We are interested in receiving
comments regarding potential environmental and interrelated economic
issues and impacts that APHIS may determine should be considered in our
evaluation of the petition. We are particularly interested in receiving
comments regarding biological, cultural, or ecological issues, and we
encourage the submission of scientific data, studies, or research to
support your comments.
After the comment period closes, APHIS will review all written
comments received during the comment period and any other relevant
information. Any substantive issues identified by APHIS based on our
review of the petition and our evaluation and analysis of comments will
be considered in the development of our decision-making documents. As
part of our decision-making process regarding a GE organism's
regulatory status, APHIS prepares a plant pest risk assessment to
assess its plant pest risk and the appropriate environmental
documentation--either an environmental assessment (EA) or an
environmental impact statement (EIS)--in accordance with the National
Environmental Policy Act (NEPA), to provide the Agency with a review
and analysis of any potential environmental impacts associated with the
petition request. For petitions for which APHIS prepares an EA, APHIS
will follow our published process for soliciting public comment (see
footnote 1) and publish a separate notice in the Federal Register
announcing the availability of APHIS' EA and plant pest risk
assessment.
Should APHIS determine that an EIS is necessary, APHIS will
complete the NEPA EIS process in accordance with Council on
Environmental Quality regulations (40 CFR part 1500-1508) and APHIS'
NEPA implementing regulations (7 CFR part 372).

Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.

Done in Washington, DC, on March 26, 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-06399 Filed 3-29-18; 8:45 am]
BILLING CODE 3410-34-P

Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices 13723

FURTHER INFORMATION CONTACT above. DEPARTMENT OF AGRICULTURE Title: Infectious Salmon Anemia;
We are interested in receiving Payment of Indemnity.
comments regarding potential Animal and Plant Health Inspection OMB Control Number: 0579–0192.
environmental and interrelated Service Type of Request: Revision to and
economic issues and impacts that [Docket No. APHIS–2018–0016] extension of approval of an information
APHIS may determine should be collection.
considered in our evaluation of the Notice of Request for Revision to and Abstract: Under the Animal Health
petition. We are particularly interested Extension of Approval of an Protection Act (7 U.S.C. 8301 et seq.),
in receiving comments regarding Information Collection; Infectious the Animal and Plant Health Inspection
biological, cultural, or ecological issues, Salmon Anemia; Payment of Indemnity Service (APHIS) of the U.S. Department
and we encourage the submission of of Agriculture is authorized, among
AGENCY: Animal and Plant Health
scientific data, studies, or research to other things, to prevent the interstate
Inspection Service, USDA.
support your comments. spread of serious diseases and pests of
ACTION: Revision to and extension of livestock within the United States when
After the comment period closes, approval of an information collection; feasible. In connection with this
APHIS will review all written comments comment request. mission, APHIS established regulations
received during the comment period in 9 CFR part 53 to pay indemnity to
SUMMARY: In accordance with the
and any other relevant information. Any Paperwork Reduction Act of 1995, this salmon producers in Maine whose fish
substantive issues identified by APHIS notice announces the Animal and Plant are destroyed because of infectious
based on our review of the petition and Health Inspection Service’s intention to salmon anemia (ISA). However,
our evaluation and analysis of request a revision to and extension of payment is subject to the availability of
comments will be considered in the approval of an information collection funding.
development of our decision-making associated with the regulations for the ISA is a foreign animal disease of
documents. As part of our decision- payment of indemnity due to infectious Atlantic salmon that is caused by an
making process regarding a GE salmon anemia. orthomyxovirus. The disease affects
organism’s regulatory status, APHIS DATES: We will consider all comments wild and farmed Atlantic salmon. ISA
prepares a plant pest risk assessment to that we receive on or before May 29, poses a substantial threat to the
assess its plant pest risk and the 2018. economic viability and sustainability of
appropriate environmental salmon aquaculture in the United
ADDRESSES: You may submit comments States.
documentation—either an by either of the following methods:
environmental assessment (EA) or an To take part in this indemnity
• Federal eRulemaking Portal: Go to program, producers must enroll in the
environmental impact statement (EIS)— http://www.regulations.gov/#!docket
in accordance with the National cooperative ISA control program
Detail;D=APHIS-2018-0016. administered by APHIS and the State of
Environmental Policy Act (NEPA), to • Postal Mail/Commercial Delivery:
Maine. Program participants must also
provide the Agency with a review and Send your comment to Docket No.
inform the ISA Program Veterinarian in
analysis of any potential environmental APHIS–2018–0016, Regulatory Analysis
writing of the name of their accredited
impacts associated with the petition and Development, PPD, APHIS, Station
veterinarian, develop biosecurity
request. For petitions for which APHIS 3A–03.8, 4700 River, Road Unit 118,
protocols and a site-specific ISA action
prepares an EA, APHIS will follow our Riverdale, MD 20737–1238.
Supporting documents and any plan, submit fish inventory and
published process for soliciting public mortality information, complete an
comment (see footnote 1) and publish a comments we receive on this docket
may be viewed at http:// appraisal and indemnity claim form,
separate notice in the Federal Register complete a proceeds from animals sold
announcing the availability of APHIS’ www.regulations.gov/#!docket
Detail;D=APHIS-2018-0016 or in our for slaughter form, and assist APHIS or
EA and plant pest risk assessment. State officials with onsite disease
reading room, which is located in Room
Should APHIS determine that an EIS 1141 of the USDA South Building, 14th surveillance, testing, and biosecurity
is necessary, APHIS will complete the Street and Independence Avenue SW, audits. Program participants, who may
NEPA EIS process in accordance with Washington, DC. Normal reading room include certain aquaculture industry
Council on Environmental Quality hours are 8 a.m. to 4:30 p.m., Monday business owners, managers, site
regulations (40 CFR part 1500–1508) through Friday, except holidays. To be employees, accredited veterinarians,
and APHIS’ NEPA implementing sure someone is there to help you, and designated laboratories, must also
regulations (7 CFR part 372). please call (202) 799–7039 before assist APHIS with certain disease
coming. surveillance activities.
Authority: 7 U.S.C. 7701–7772 and 7781– We are asking the Office of
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and FOR FURTHER INFORMATION CONTACT: For Management and Budget (OMB) to
371.3. information on the regulations for the approve our use of these information
Done in Washington, DC, on March 26, payment of indemnity due to infectious collection activities, as described, for an
2018. salmon anemia, contact Mrs. Teresa additional 3 years.
Robinson, USDA–APHIS–VS, Maine The purpose of this notice is to solicit
Kevin Shea,
ISA Program Aquaculture Liaison, 253 comments from the public (as well as
Administrator, Animal and Plant Health King Street, Edmunds Township, ME
Inspection Service. affected agencies) concerning our
04628; (207) 319–3703. For copies of
amozie on DSK30RV082PROD with NOTICES

[FR Doc. 2018–06399 Filed 3–29–18; 8:45 am]
information collection. These comments
more detailed information on the will help us:
BILLING CODE 3410–34–P information collection, contact Ms. (1) Evaluate whether the collection of
Kimberly Hardy, APHIS’ Information information is necessary for the proper
Collection Coordinator, at (301) 851– performance of the functions of the
2483. Agency, including whether the
SUPPLEMENTARY INFORMATION: information will have practical utility;

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Document Created: 2018-11-01 08:57:59
Document Modified: 2018-11-01 08:57:59

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		We will consider all comments that we receive on or before May 29, 2018.
Contact		Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected] To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected]
FR Citation		83 FR 13722

83 FR 13722 - BASF Plant Science, LP; Availability of Petition for Determination of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile and Resistance to an Imidazolinone Herbicide

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 83, Issue 62 (March 30, 2018)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service